Summary

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• Epidiolex (cannabidiol) is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or Tuberous sclerosis complex in patients 1 year of age and older.
• This summary is based on the review of 20 systematic review(s)/meta-analysis(es). ^[1-20]
• Cannabidiol (CBD) demonstrated substantial reductions in seizure frequency in pediatric patients with Dravet Syndrome (DS), with some achieving seizure freedom, though it was less effective than stiripentol and fenfluramine in achieving significant seizure reductions.
• CBD was effective in reducing seizure frequency in Lennox-Gastaut Syndrome (LGS) and DS, though it showed less efficacy in adult focal epilepsy and was slightly inferior to other antiseizure medications like stiripentol and fenfluramine.
• In pediatric patients with drug-resistant epilepsy, including DS and LGS, CBD was associated with a significant reduction in seizure frequency, achieving ≥50% reduction in some cases, though this efficacy was not observed uniformly across all epilepsy syndromes.
• Across several pediatric epilepsy syndromes, including DS, LGS, and tuberous sclerosis complex (TSC), CBD showed good efficacy, although it was slightly less effective than stiripentol and fenfluramine in specific populations.
• Cannabidiol (CBD) was associated with a higher incidence of adverse events (AEs), particularly somnolence, decreased appetite, diarrhea, and elevated serum aminotransferases, compared to placebo.
• The use of cannabidiol increased the probability of liver enzyme elevation and drug-induced liver injury (DILI), especially at doses ≥1000 mg/day or with concomitant antiepileptic drugs.
• No significant differences in serious adverse events (SAEs) were observed between cannabidiol, stiripentol, and fenfluramine; however, cannabidiol had a higher frequency of serious AEs and dose reductions compared to placebo.
• Cannabidiol consistently demonstrated efficacy in reducing seizure frequency with a generally acceptable safety profile, though with increased risks of adverse effects. It is less effective in adults with focal epilepsy and presents notable adverse events in patients with Lennox-Gastaut Syndrome (LGS) and children with drug-resistant epilepsy, particularly gastrointestinal effects and liver enzyme elevations. There is no significant efficacy observed in adult populations with focal epilepsy.